flecainide acetate 100 mg
INDICATIONS AND USAGE In patients without structural heart disease, flecainide acetate is indicated for the prevention of: • paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms • paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms Flecainide acetate is also indicated for the prevention of: • documented ventricular arrhythmias, such as sustained ventricular tachycardia ( sustained VT), that in the judgment of the physician are life-threatening. Use of flecainide acetate for the treatment of sustained VT, like other antiarrhythmics, should be initiated in the hospital. The use of flecainide acetate is not recommended in patients with less severe ventricular arrhythmias even if the patients are symptomatic. Because of the proarrhythmic effects of flecainide acetate tablets, its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment outweigh the risks. Flecainide acetate should not be used in patients with recent myocardial infarction. (See Boxed WARNINGS .) Use of flecainide acetate in chronic atrial fibrillation has not been adequately studied and is not recommended. (See Boxed WARNINGS .) As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of flecainide acetate favorably affects survival or the incidence of sudden death.
Hikma Pharmaceuticals USA Inc.
ROUND WHITE 54 070
54 070 ROUND WHITE
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HOW SUPPLIED
FLECAINIDE ACETATE Tablets, USP 50 mg tablet is supplied as a white, round, biconvex tablet with product identification “54 024” debossed on one side and plain on the other side. NDC 0054-0010-21: Bottle of 60 Tablets NDC 0054-0010-25: Bottle of 100 Tablets NDC 0054-0010-20: 10x10 Unit-Dose Tablets 100 mg tablet is supplied as a white, round, biconvex tablet with product identification “54 070” debossed on one side and a deep bisect on the other. NDC 0054-0011-21: Bottle of 60 Tablets NDC 0054-0011-25: Bottle of 100 Tablets NDC 0054-0011-20: 10x10 Unit-Dose Tablets 150 mg tablet is supplied as a white, capsule shaped, biconvex tablet with product identification “54 150” debossed on one side and a score on the other. NDC 0054-0012-21: Bottle of 60 Tablets NDC 0054-0012-25: Bottle of 100 Tablets NDC 0054-0012-20: 10x10 Unit-Dose Tablets Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container. Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 C50000555/01 Revised June 2023
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